Abstract
This article introduces the white paper from the 2017 Viral Clearance Symposium. The 5th Viral Clearance Symposium in Penzberg, Germany, addressed regulatory perspectives presented by officials from Health Canada, the US Food and Drug Administration, and Paul-Ehrlich-Institut as well as upstream and facility risk mitigation, downstream unit operations, and viral clearance strategies to support novel molecule formats, accelerated scenarios, and continuous processing.
LAY ABSTRACT: This article introduces the summarized findings and next steps from the 2017 Viral Clearance Symposium in Penzberg, Germany.
- Viral clearance
- Viral safety
- Viral Clearance Symposium
- Upstream processing
- Downstream processing
- Resin lifetime
- Facility risk mitigation
- Submission
- Strategy
- Regulatory agencies
- Health Canada
- FDA
- PEI
- Regulatory perspective
- Novel format molecules
- Continuous processing
- © PDA, Inc. 2018
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